FDA Adverse Event Malfunction Summary report: N

DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM

MDR report key: 4012497 · Received August 15, 2014

Report

Report Number: 1226181-2014-00426
Event Type: Malfunction
Date Received: August 15, 2014
Date of Event: July 22, 2014
Report Date: July 22, 2014
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Product Code: JJE
PMA / PMN Number: K051087
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE TRANSFERRED THE CALCIUM METHOD TO SERVER 3 AND RECALIBRATED. THE SIEMENS CUSTOMER CARE CENTER AND A SIEMENS TECHNICAL APPLICATION SPECIALIST REVIEWED DATA FROM THE INSTRUMENT AND DETERMINED THAT THERE HAD BEEN NO DISCORDANT RESULTS AFTER TRANSITIONING THE METHOD TO SERVER 3. THE CAUSE OF THE DISCORDANT CALCIUM RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

Description of Event or Problem · 1

A DISCORDANT, FALSELY LOW CALCIUM RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FIVE TIMES ON THE SAME INSTRUMENT AND ALL RESULTS WERE HIGHER THAN THE INITIAL RESULT. IT IS UNKNOWN IF THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CALCIUM RESULT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
489514	DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM	CLINICAL CHEMISTRY ANALYZER	JJE	SIEMENS HEALTHCARE DIAGNOSTICS INC.	DIMENSION VISTA 1500

Patients

Seq	Age	Sex	Outcome	Treatment
1